Advanced Imaging Registry for Diagnosing Pancreatico-biliary Disorders

• Conditions: Diagnosis of a Pancreaticobiliary Disorder
• Interventions: Procedure: Endoscopy

• Registration Number: NCT02166086
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

The purpose of this registry is to record information and evaluate the impact of advanced imaging techniques on the management of pancreatico-biliary disorders. The registry will evaluate diagnostic performance and overall clinical management impacted by advanced imaging techniques.

Detailed Description

Advanced imaging techniques such as SpyGlass or pCLE (probe-based Confocal laser endomicroscopy) using Cellvizio probes enable high sensitive and specific diagnosis of strictures or tumors in bile and pancreatic ducts. However, advanced endoscopists have only recently started to employ such techniques for diagnostic purposes. Hence we lack enough data to evaluate the sensitivity, specificity, accuracy, technical feasibility and safety of such imaging devices. Evaluation of these factors would help us compare them to conventional diagnostic options; and consequently help us identify appropriate advanced imaging techniques for biliary and pancreatic disorders and improve clinical management of patients.

The purpose of this registry is to record information and evaluate the impact of advanced imaging techniques on the management of pancreatico-biliary disorders. The registry will evaluate diagnostic performance and overall clinical management impacted by advanced imaging techniques.

This multi-center registry has been initiated:

* To document the impact of advanced imaging techniques in pancreatico-biliary disorders on the clinical management of pancreatico-biliary disorders including malignancies.

* To assess the sensitivity, specificity, accuracy, technical feasibility and safety of advanced imaging techniques in pancreatico-biliary disorders.

The registry will review and document:

* All patients who have had advanced imaging done for pancreatico-biliary disorders.

* No subject intervention is involved in this study. Subject contact is not needed for database review.

Study Design at Secondary sites:

* Other sites must have either a database review protocol and/or a clinical trial that would collect data on advanced imaging done for pancreatico-biliary disorders prior to participating in the registry.

* These sites would have IRB approved protocols to collect and send advanced imaging procedure data to the primary site (WCMC). Additionally, the secondary study sites would mention WCMC as an entity that could receive PHI in their respective protocols and consent/HIPAA forms.

* All secondary study sites' IRB approvals will be sent to the primary/coordinating study center at WCMC. The primary center will then forward these IRB approvals to WCMC IRB as soon as they are received from the secondary study sites.

* Relevant IRB documentation will be maintained at both primary and secondary sites.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-13
• Study First Posted: 2014-06-18
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-20
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Any patient who has undergone advanced imaging procedures for diagnosis and/or treatment of a pancreatico-biliary disorder.
• Above 18 years of age.

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Exclusion Criteria

• Any patient who has not undergone advanced imaging techniques for pancreatico-biliary disorders.
• Below 18 years of age.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endoscopic imaging	Endoscopy	Any patient who has undergone advanced imaging procedures for diagnosis and/or treatment of a pancreatico-biliary disorder.

Primary Outcome Measures

Name	Time	Method
Efficacy Profile	1 year	Documentation of accuracy, sensitivity, specificity, positive predictive value, negative predictive value based on final diagnosis variable analyses.

Secondary Outcome Measures

Name	Time	Method
Survival duration	1 year or more	Documentation of follow up diagnoses variable and survival duration (in days).

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States